Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 22
Filter
1.
J Pediatr Urol ; 19(5): 537.e1-537.e6, 2023 10.
Article in English | MEDLINE | ID: mdl-37244838

ABSTRACT

INTRODUCTION: Florida Medicaid will only cover a non-neonatal circumcision if it meets the specified Medicaid medical indications or the patient is 3 years or older and has failed a 6-week trial of topical steroid therapy (TST). Referral of children who do not meet guideline criteria results in unnecessary costs. OBJECTIVE: We sought to evaluate the cost savings if the initial evaluation and management were performed by the primary care provider (PCP) with referral to a pediatric urologist of only those males meeting the guidelines. STUDY DESIGN: An institutional review board-approved retrospective chart review of all male pediatric patients ≥3 years of age presenting for phimosis/circumcision from September 2016 to September 2019 at our institution was performed. Data extracted included (1) presence of phimosis, (2) presence of medical indication for circumcision on presentation, (3) circumcision performed without meeting criteria, (4) use of topical steroid therapy prior to referral. The population was stratified into 2 groups based on whether criteria were met at the time of referral. Those with a defined medical indication on presentation were excluded from cost analysis. Cost savings were based on costs incurred for PCP visit(s) versus initial referral to a urologist using estimated Medicaid reimbursement rates. RESULTS: Of the 763 males, 76.1% (581) did not meet Medicaid criteria for circumcision on presentation. Of these, 67 had a retractable foreskin with no medical indication, 514 had phimosis with no documented topical steroid therapy (TST) failure. A savings of $95,704.16 would have been incurred if the PCP initiated the evaluation and management and referred only those who met the criteria (Table 2). DISCUSSION: These savings would only be feasible if there were proper education of PCPs in the evaluation of phimosis and the role of TST. Limitations are assuming cost savings in the setting of well-educated pediatricians for clinical exam and believing they are aware of and comply with the guidelines. CONCLUSIONS: Education of PCPs on the role of TST in phimosis and current Medicaid guidelines may reduce unnecessary office visits, health care costs, and family burden. The most impactful method to reduce the cost of non-neonatal circumcision would be for states that do not currently cover neonatal circumcision to acknowledge affirmative policies from the American Academy of Pediatrics regarding circumcision and realize the cost savings associated with providing coverage for neonatal circumcision and reducing significantly the number of more expensive non-neonatal circumcisions.


Subject(s)
Circumcision, Male , Phimosis , Infant, Newborn , Humans , Male , Child , United States , Florida , Medicaid , Retrospective Studies , Circumcision, Male/methods , Health Care Costs , Steroids
2.
Pediatr Radiol ; 52(2): 200-216, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34152437

ABSTRACT

Female Müllerian anomalies are the result of failure of formation, fusion or resorption of the Müllerian ducts and are relatively common, with a prevalence of 5.5-7.0% in the general population. While some of these anomalies are asymptomatic, those presenting with obstruction require accurate identification for optimal clinical management including potential surgical treatment. MRI is a useful adjunct to sonography in the evaluation of Müllerian anomalies, typically allowing a more complete characterization of the malformation. Technical aspects, embryologic concepts and controversies regarding classification systems are highlighted in this review. Several Müllerian anomalies are discussed and illustrated in more detail utilizing various cases with pelvic MRI studies.


Subject(s)
Uterus , Vagina , Female , Humans , Magnetic Resonance Imaging , Mullerian Ducts/diagnostic imaging , Ultrasonography , Uterus/diagnostic imaging , Vagina/diagnostic imaging
3.
Urol Case Rep ; 33: 101360, 2020 Nov.
Article in English | MEDLINE | ID: mdl-33102059

ABSTRACT

The differential diagnosis of scrotal pain and swelling in adolescent males includes testicular and appendage torsion, epididymitis, epididymo-orchitis, trauma and incarcerated hernia. Physical examination, ultrasound and urinalysis often can identify the etiology of the scrotal pain and swelling. We present a case of left scrotal pain and swelling that was initially concerning for a paratesticular mass. Repeat examination and further imaging during pre-operative assessment was consistent with left-sided vasitis. The diagnosis of vasitis is difficult with ultrasound and commonly requires CT or MRI to differentiate from incarcerated inguinal hernia. Recognition of this uncommonly reported condition may prevent unnecessary surgeries.

4.
J Surg Case Rep ; 2020(4): rjaa058, 2020 Apr.
Article in English | MEDLINE | ID: mdl-32280441

ABSTRACT

Although perforated appendicitis in pediatric patients can result in a diverse array of complications, scrotal abscess is a rarely documented phenomenon. We present a case of acute scrotum after laparoscopic appendectomy. A retrospective review of prior literature on scrotal abscess secondary to perforated appendicitis was performed via PubMed to review the clinical presentation, etiology, type of treatment and outcome of pediatric patients. Patients without a patent processus vaginalis still require vigilant follow-up postoperatively to ensure timely intervention if scrotal pain develops during recovery.

5.
Urology ; 101: 139-141, 2017 Mar.
Article in English | MEDLINE | ID: mdl-27840250

ABSTRACT

Eosinophilic cystitis (EC) is an uncommon inflammatory disorder of uncertain etiology that has been described in adult and pediatric populations. We describe 3 recent cases of EC that presented as a mass lesion in pediatric patients from the New England region of the United States. All patients were initially suspected to have a malignancy, and biopsy was performed, which ultimately led to the diagnosis of EC. We propose the use of eosinophil density of >25 eosinophils per high-power field and myocyte degeneration as supportive histopathologic features to make this diagnosis. It is of utmost importance to consider EC in the differential diagnosis when approaching a pediatric patient with a bladder mass.


Subject(s)
Cystitis/diagnosis , Eosinophilia/diagnosis , Eosinophils/pathology , Urinary Bladder/diagnostic imaging , Adolescent , Anti-Inflammatory Agents/administration & dosage , Biopsy , Child, Preschool , Cystitis/therapy , Diagnosis, Differential , Eosinophilia/therapy , Humans , Hydrocortisone/administration & dosage , Leukocyte Count , Magnetic Resonance Imaging , Male , Tomography, X-Ray Computed , Ultrasonography , Urologic Surgical Procedures, Male/methods , Urothelium/pathology
7.
J Urol ; 190(3): 1021-6, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23500640

ABSTRACT

PURPOSE: We evaluated outcomes of nonoperative management of primary nonrefluxing megaureter at long-term followup to identify clinical predictors of spontaneous resolution. MATERIALS AND METHODS: A total of 75 patients (88 primary megaureters) were diagnosed between 1990 and 2005 and followed for more than 6 months. Of the patients 63 (74 primary megaureters) were included in the main study population. Indications for surgery were obstructive hydroureteronephrosis, functional impairment and persistent symptoms. RESULTS: Of the 74 primary megaureters 20 (27%) required surgery up to 7 years after diagnosis. Surgery was not indicated in 82% of primary megaureters with grade I or II hydronephrosis vs 62.9% of those with grade III or higher hydronephrosis (difference not significant), nor in 76.5% of types I and II primary megaureters vs 33.3% of type III primary megaureters (p = 0.040), 78.7% of renal units with differential function 40% or greater vs 0% with differential function less than 40% (p = 0.027), 80% of primary megaureters with a nonobstructive washout pattern vs 44.4% with an intermediate/obstructive pattern (p = 0.032), 67.9% of patients with perinatal presentation vs 25% with postneonatal presentation (p = 0.008) or 63.2% of patients presenting with symptoms vs 76.4% of those who were asymptomatic (difference not significant). On multivariate analysis age at presentation and washout pattern were significant predictors of spontaneous resolution. CONCLUSIONS: Most cases of primary megaureter resolve spontaneously or improve without loss of function or development of symptoms. Careful observation allows surgery to be delayed beyond the neonatal period in most patients. Long-term followup is recommended because symptoms can develop years later. Washout pattern and age at presentation are statistically significant predictors of spontaneous resolution.


Subject(s)
Remission, Spontaneous , Ureter/abnormalities , Ureteral Obstruction/therapy , Urogenital Abnormalities/therapy , Child , Child, Preschool , Cohort Studies , Confidence Intervals , Disease Progression , Female , Follow-Up Studies , Humans , Infant , Infant, Newborn , Kaplan-Meier Estimate , Logistic Models , Male , Odds Ratio , Patient Selection , Radioisotope Renography , Retrospective Studies , Risk Assessment , Time Factors , Treatment Outcome , Ureter/pathology , Ureteral Obstruction/complications , Ureteral Obstruction/surgery , Urogenital Abnormalities/diagnosis , Vesico-Ureteral Reflux
8.
J Pediatr Urol ; 7(4): 438-40, 2011 Aug.
Article in English | MEDLINE | ID: mdl-21672652

ABSTRACT

OBJECTIVE: Dextranomer-hyaluronic acid (DxHA) injection is an accepted treatment for vesicoureteral reflux (VUR), with success rates as high as 85-90% in selected patients. The DxHA mound can often be seen on postoperative ultrasound. We sought to determine whether the presence or absence of this mound on ultrasound can predict resolution of VUR on voiding cystourethrogram (VCUG). MATERIALS AND METHODS: A retrospective study evaluating patients who underwent cystoscopy and injection of DxHA from 2003 to the present was performed. Demographic variables, laterality and grade of VUR, postoperative ultrasound findings, and presence of VUR on postoperative VCUG were recorded. RESULTS: Fifty-one patients (95 ureters) underwent DxHA injection and had a postoperative ultrasound and VCUG for review. Five patients with persistent voiding dysfunction were excluded, leaving 46 patients and 86 ureters for review. The mean age at time of injection was 5.2 years (range 0.75-11 years) and mean grade of VUR was 2.5 (range 1-5). After DxHA injection, 75% of the ureters showed resolution of VUR, while 25% demonstrated persistent VUR. No correlation was made between the presence of DxHA mound and resolution of VUR on VCUG. CONCLUSION: In this series, the presence of a DxHA mound on initial postoperative ultrasound does not predict resolution of VUR. A larger prospective study is needed to evaluate additional parameters.


Subject(s)
Cystoscopy , Dextrans/therapeutic use , Hyaluronic Acid/therapeutic use , Postoperative Complications/diagnostic imaging , Vesico-Ureteral Reflux/diagnostic imaging , Vesico-Ureteral Reflux/therapy , Child , Child, Preschool , Humans , Infant , Predictive Value of Tests , Retrospective Studies , Treatment Outcome , Ultrasonography , Ureter/diagnostic imaging , Urination/physiology , Vesico-Ureteral Reflux/surgery
9.
Neurourol Urodyn ; 30(4): 563-7, 2011 Apr.
Article in English | MEDLINE | ID: mdl-21268101

ABSTRACT

AIMS: Once-daily extended release (XR) trospium chloride, which provides therapeutic trospium plasma concentrations over 24 hours, has demonstrated efficacy in treating overactive bladder (OAB) symptoms as evaluated over a 24-hr period. This analysis examined the effects of trospium XR on diurnal and nocturnal OAB symptoms. METHODS: Pooled data were analyzed from two identically designed Phase III trials in which patients with OAB were randomized to receive trospium XR 60 mg or placebo once daily in the morning for 12 weeks. Efficacy was assessed using 3-day urinary diaries. Diurnal events were those occurring from arising from bed in the morning until retiring in the evening; nocturnal events were those occurring from retiring until arising. RESULTS: In total, 1,165 patients received trospium XR (N = 578) or placebo (N = 587). At Week 12 comparison of trospium XR versus placebo, a significantly greater mean reduction from baseline in nocturnal voids (-0.8 vs. -0.6; P = 0.006) and diurnal voids (-1.9 vs. -1.4; P < 0.0001) was noted. At Week 12, the mean percent reduction from baseline with trospium XR versus placebo in nocturnal urge urinary incontinence (UUI) episodes (-60.2% vs. -48.3%; P = 0.003) and mean absolute reduction in diurnal UUI episodes (-2.0 vs. -1.5; P < 0.0001) was significantly greater. Predictors of nocturnal response were duration (weeks) and type of therapy (trospium XR vs. placebo). Reductions in nocturnal toilet voids were accompanied by significant improvements in sleep-related quality of life (QoL) domains. CONCLUSIONS: Trospium XR significantly improved both nocturnal and diurnal OAB symptoms. Nocturnal improvements were associated with sleep-related QoL benefits. These results indicate that the XR formulation of trospium chloride provides effective 24-hr coverage of OAB symptoms.


Subject(s)
Nortropanes/therapeutic use , Parasympatholytics/therapeutic use , Urinary Bladder, Overactive/drug therapy , Urinary Incontinence/drug therapy , Benzilates , Delayed-Action Preparations , Double-Blind Method , Drug Administration Schedule , Female , Humans , Male , Nortropanes/administration & dosage , Parasympatholytics/administration & dosage , Treatment Outcome
10.
Urology ; 77(1): 24-9, 2011 Jan.
Article in English | MEDLINE | ID: mdl-20970833

ABSTRACT

OBJECTIVES: This study used pooled data from 2 large, phase III, double-blind, randomized, placebo-controlled studies for a subgroup analysis of the safety and efficacy of trospium chloride extended-release (XR) in men with overactive bladder (OAB). METHODS: A subgroup analysis was performed on data from the 176 male patients (trospium XR, 94; placebo, 82) who participated in 1 of the 2 studies. Patients received either trospium XR 60 mg or placebo once daily for 12 weeks. RESULTS: The mean age was 66.2 years for trospium XR and 63.1 years for placebo. A history of benign prostatic hyperplasia was recorded for 29 trospium XR recipients (30.9%) and 23 placebo recipients (28.0%). A total of 19 patients (20.2%) receiving trospium XR and 15 (18.3%) receiving placebo experienced ≥1 treatment-emergent adverse event considered at least possibly related to the study medication. Two trospium XR patients (2.1%) developed urinary retention; both were aged ≥75 years, and 1 had a history of prostate enlargement. Treatment with trospium XR compared with placebo resulted in significantly greater decreases from baseline in the mean number of daily toilet voids (-2.5 vs -1.5; P < .05) and urgency urinary incontinence episodes (-2.3 vs -1.4; P < .05) in men at week 12 (the coprimary efficacy variables). CONCLUSIONS: Trospium XR is safe and effective in men with OAB. The risk of urinary retention is low and may be further decreased by careful patient selection.


Subject(s)
Nortropanes/administration & dosage , Parasympatholytics/administration & dosage , Urinary Bladder, Overactive/drug therapy , Adult , Aged , Aged, 80 and over , Benzilates , Delayed-Action Preparations , Double-Blind Method , Drug Administration Schedule , Humans , Male , Middle Aged , Nortropanes/adverse effects , Parasympatholytics/adverse effects , Safety
11.
J Pediatr Urol ; 7(1): 95-7, 2011 Feb.
Article in English | MEDLINE | ID: mdl-21071280

ABSTRACT

Post-void residual (PVR) determination is an integral part of the evaluation of children presenting with lower urinary tract symptoms. Historically the PVR volume has been obtained by urinary catheterization after the child has voided, however, with the advent of ultrasound technology, PVR was determined in a noninvasive fashion by radiology personnel. Currently, PVR determinations may be obtained by healthcare personnel (without specialized training) using a portable, self calculating ultrasound; the BladderScan. While BladderScan PVR has been shown to be accurate and reproducible, it cannot differentiate between a distended bladder and other cystic pelvic structures. Several case reports have been published illustrating falsely elevated PVRs by bladder scan in adults with cystic pelvic structures. We present two adolescent females with LUTS who had falsely elevated PVRs by bladder scan, who, subsequently, underwent formal imaging to identify ovarian cystic pathology. To our knowledge, this is the first report of falsely elevated bladder scan PVR in children related to cystic pelvic organ pathology.


Subject(s)
Diagnostic Techniques, Urological , Ovarian Cysts/complications , Ovarian Cysts/diagnosis , Urinary Bladder/physiopathology , Urination Disorders/diagnosis , Urination Disorders/etiology , Adolescent , Diagnosis, Differential , Diagnostic Errors , Female , Humans , Tomography, X-Ray Computed , Ultrasonography , Urinary Bladder/diagnostic imaging , Urinary Catheterization , Urination Disorders/physiopathology , Urination Disorders/therapy , Urine
12.
BJU Int ; 107(4): 612-20, 2011 Feb.
Article in English | MEDLINE | ID: mdl-20707790

ABSTRACT

OBJECTIVE: • To evaluate the safety and efficacy of once-daily trospium chloride extended release (ER) in overactive bladder syndrome (OAB) in subjects aged ≥ 75 years. SUBJECTS AND METHODS: • The analysis included subjects ≥ 75 years of age with OAB. • A subgroup analysis of pooled data was performed for subjects aged ≥ 75 years from two randomized, double-blind, multicenter studies of subjects with OAB receiving once-daily trospium 60 mg extended release (ER) or placebo for 12 weeks, followed by 9-month open-label extension periods during which all subjects received trospium ER. A total of 143 of the 1165 subjects from two phase III registration trials who were aged ≥ 75 years (85 trospium ER, 58 placebo; mean age 79 years and ranging up to 90 years; 73% female) were evaluated. • Dual primary efficacy variables were the changes from baseline in the average number of toilet voids per day and urge urinary incontinence episodes per day. RESULTS: • At week 12 of the double-blind period, trospium ER produced greater improvements from baseline than placebo in voiding diary parameters, OAB Patient Global Assessment, and quality of life. • Efficacy and tolerability persisted among subjects receiving open-label trospium ER for up to 1 year. CONCLUSIONS: • Once-daily trospium chloride 60 mg ER demonstrated efficacy vs placebo and was tolerated in subjects aged ≥ 75 years with OAB. • For subjects who continued into the open-label treatment period, efficacy and tolerability were observed for up to 1 year.


Subject(s)
Muscarinic Antagonists/therapeutic use , Nortropanes/therapeutic use , Urinary Bladder, Overactive/drug therapy , Aged , Aged, 80 and over , Benzilates , Delayed-Action Preparations , Epidemiologic Methods , Female , Humans , Male , Muscarinic Antagonists/adverse effects , Nortropanes/adverse effects , Patient Satisfaction , Quality of Life , Treatment Outcome
13.
J Urol ; 184(4 Suppl): 1620-4, 2010 Oct.
Article in English | MEDLINE | ID: mdl-20728127

ABSTRACT

PURPOSE: We evaluated which clinical factors influence the outcome of primary transurethral puncture for ureterocele. MATERIALS AND METHODS: A total of 45 patients (47 ureteroceles) underwent primary transurethral incision between 1994 and 2008 at 2 institutions. Age at and mode of presentation, upper tract status, ureterocele site, preoperative vesicoureteral reflux and the corresponding upper pole or kidney function were analyzed to identify which factors influenced the need for secondary surgery. RESULTS: Transurethral puncture was the only treatment in 24 of 45 patients (53%) while 21 (47%) required further surgery. After transurethral puncture secondary surgery was required in 56% of patients who presented prenatally vs 27% of those who presented postnatally (p = 0.165), in 18% with a single system vs 58% with a duplex system (p = 0.036), in 30% with intravesical vs 63% with ectopic ureterocele (p = 0.039) and in 61% vs 37% with ureterocele units with vs without preoperative vesicoureteral reflux (p = 0.148). Fisher's 2-tailed exact test revealed an inconsistent distribution of negative prognostic factors, including duplex systems, ectopic ureterocele and vesicoureteral reflux at presentation, in prenatally vs postnatally and in asymptomatically vs symptomatically presenting subgroups. CONCLUSIONS: Upper tract status and ureterocele site influence the outcome of primary transurethral puncture as a definitive procedure. After puncture secondary surgery is least likely in patients with a single system and intravesical ureterocele.


Subject(s)
Ureterocele/therapy , Female , Humans , Infant , Infant, Newborn , Male , Punctures/methods , Retrospective Studies , Treatment Outcome , Urethra
15.
J Pediatr Urol ; 5(4): 321-3, 2009 Aug.
Article in English | MEDLINE | ID: mdl-19329362

ABSTRACT

Children presenting with nonpalpable undescended testes are evaluated with diagnostic laparoscopy. The laparoscopic findings of blind-ending vessels and vas deferens are felt to be diagnostic for 'vanished' testes. We present a case of an overweight male in whom the testis was not palpable in the office or under anesthesia and in whom blind-ending vessels were identified on laparoscopy. Inguinal exploration revealed a normal appearing inguinal testis. Although not advocated as a tool in the evaluation of the child presenting with an undescended testis, inguinal ultrasound may have a role in overweight children in whom the examination may be difficult. Furthermore, we would advocate inguinal exploration in overweight children, given the limitations of laparoscopy in this overweight child.


Subject(s)
Cryptorchidism/diagnosis , Laparoscopy , Physical Examination , Testis/abnormalities , Child , Humans , Inguinal Canal , Male , Overweight
16.
J Pediatr Urol ; 4(6): 428-33, 2008 Dec.
Article in English | MEDLINE | ID: mdl-19013412

ABSTRACT

OBJECTIVE: We evaluated long-term (> or =12 months) efficacy and safety of tolterodine in children with neurogenic detrusor overactivity. SUBJECTS AND METHODS: Subjects successfully completed one of three 12-week, open-label studies and had stable neurologic disease and urodynamic evidence of neurogenic detrusor overactivity requiring intermittent catheterization. Drug formulation and dosing were based on age (4 months-4 years, tolterodine oral solution 0.2-2mg twice daily; 5-10 years, tolterodine oral solution 0.5-4 mg twice daily; 11-16 years, tolterodine extended-release capsules 2, 4, or 6 mg once daily). Daily doses were individualized for each subject. Efficacy was evaluated urodynamically and using parent-completed 3-day bladder diaries. RESULTS: Thirty subjects were enrolled. Functional bladder capacity (volume at first leakage, first sensation of bladder fullness or 40 cm H(2)O pressure) increased by month 12 in the younger age groups but not in the oldest subjects. Volume to first detrusor contraction >10 cm H(2)O pressure and detrusor leak point pressure did not change in any age group. The number of incontinence episodes per 24h decreased in all subjects, as did the number of catheterizations per 24h. Mean volume per catheterization increased in all subjects. Seven treatment-related adverse events were reported. CONCLUSIONS: Both tolterodine formulations were effective and well tolerated in children with neurogenic detrusor overactivity.


Subject(s)
Benzhydryl Compounds/administration & dosage , Cresols/administration & dosage , Muscarinic Antagonists/administration & dosage , Muscle Hypertonia/drug therapy , Phenylpropanolamine/administration & dosage , Adolescent , Benzhydryl Compounds/adverse effects , Child , Child, Preschool , Cresols/adverse effects , Female , Humans , Infant , Male , Muscarinic Antagonists/adverse effects , Muscle Hypertonia/physiopathology , Patient Satisfaction , Phenylpropanolamine/adverse effects , Tolterodine Tartrate , Treatment Outcome , Urinary Bladder/drug effects , Urinary Bladder/physiology , Urodynamics
17.
Urology ; 71(6): 1055-8; discussion 1058, 2008 Jun.
Article in English | MEDLINE | ID: mdl-18372024

ABSTRACT

OBJECTIVES: To determine the utility of the 1-year postoperative renal ultrasound scan in children undergoing uncomplicated Cohen cross-trigonal ureteral reimplantation. METHODS: A retrospective review of 108 patients (233 ureters) who had undergone uncomplicated Cohen cross-trigonal ureteral reimplantation during a 6.5-year period with a postoperative follow-up of 1 year was performed. Renal ultrasound scans were obtained at 1 month and 1 year postoperatively. RESULTS: Of the 108 patients who had undergone ureteral reimplantation, 26 patients (24%) had mild to moderate hydronephrosis at 1 month postoperatively. Of these 26 patients, 20 had preexisting hydronephrosis and 6 had new hydronephrosis. Of the 20 patients with preoperative hydronephrosis, 19 (95%) had similar hydronephrosis on the 1-month postoperative ultrasound scan and in 1 (5%), the hydronephrosis had resolved. At 1 year, 13 (69%) of the 20 patients with preoperative hydronephrosis had stable hydronephrosis, and it resolved in 6 (31%). In the 6 patients with new-onset hydronephrosis at 1 month postoperatively, the hydronephrosis had resolved by 1 year in 4 patients (67%) and was mild in 2 (33%). Three patients developed transient obstruction requiring stent placement. CONCLUSIONS: It has been recommended that a renal ultrasound scan be obtained in children 1 year after open ureteral reimplantation to rule out delayed obstruction. Our results suggest this is of low yield in patients with uncomplicated open ureteral reimplantation.


Subject(s)
Hydronephrosis/surgery , Kidney/diagnostic imaging , Ureter/surgery , Vesico-Ureteral Reflux/surgery , Adolescent , Child , Child, Preschool , Female , Humans , Infant , Male , Postoperative Care , Retrospective Studies , Time Factors , Ultrasonography , Urologic Surgical Procedures, Male/methods
18.
J Urol ; 174(4 Pt 2): 1647-51; discussion 1651, 2005 Oct.
Article in English | MEDLINE | ID: mdl-16148673

ABSTRACT

PURPOSE: Three exploratory studies were conducted to investigate the pharmacokinetics (PK) and safety of tolterodine in children 1 month to 15 years old with neurogenic detrusor overactivity. We urodynamically evaluated the dose and concentration effects of tolterodine to establish safe and effective dosing regimens. MATERIALS AND METHODS: Three open-label, dose escalating studies were conducted in children with stable neurological disease and detrusor overactivity. In studies 1 (patient aged 1 month to 4 years) and 2 (5 to 10 years) patients received 0.03, 0.06 and 0.12 mg/kg tolterodine solution day twice daily for 4 weeks each. In study 3 (patient age 11 to 15 years) patients received 2, 4 and 6 mg tolterodine extended-release capsules once daily for 4 weeks each. PK was assessed after 8 weeks, urodynamic assessments were conducted after each 4-week dosing period and 3-day micturition diaries were completed. RESULTS: Patients in studies 1 (19) and 2 (15) showed some dose related increases in volume to first detrusor contraction and cystometric bladder capacity. In study 3 (11 patients) there were no obvious dose-response relationships. PK results from studies 1 and 2 suggest that there was no apparent effect of age (< or =10 y) on these parameters. In study 3 time of maximum observed serum concentration and apparent terminal half-life were delayed, which is consistent with the extended-release formulation. Tolterodine was well tolerated, and there was no apparent relationship between tolterodine dose and adverse events in any study. CONCLUSIONS: These results support the safety of age and body weight adjusted dosing regimens for further clinical evaluation of tolterodine in children with neurogenic detrusor overactivity.


Subject(s)
Benzhydryl Compounds/pharmacokinetics , Cresols/pharmacokinetics , Muscarinic Antagonists/pharmacokinetics , Phenylpropanolamine/pharmacokinetics , Urinary Bladder, Neurogenic/drug therapy , Adolescent , Area Under Curve , Benzhydryl Compounds/administration & dosage , Child , Child, Preschool , Cresols/administration & dosage , Delayed-Action Preparations , Dose-Response Relationship, Drug , Female , Humans , Infant , Male , Muscarinic Antagonists/administration & dosage , Phenylpropanolamine/administration & dosage , Safety , Tolterodine Tartrate , Treatment Outcome , Urinary Bladder/drug effects , Urodynamics/drug effects
19.
BJU Int ; 96(6): 857-63, 2005 Oct.
Article in English | MEDLINE | ID: mdl-16153217

ABSTRACT

OBJECTIVE: To determine whether patients with erectile dysfunction (ED) and treated with tadalafil use the 36-h duration of effect of the drug, and to discern if the timing of intercourse attempts is influenced by patient age, baseline severity of ED, or previous experience with sildenafil citrate. PATIENTS AND METHODS: In 11 multicentre, double-blind, placebo-controlled studies, 2102 patients with ED were randomized to a maximum of one dose per day of tadalafil 10 or 20 mg (1464 men), or placebo (638 men) with no time restrictions before attempting sexual activity after the dose. A post hoc analysis was used to determine the proportion of men with ED who attempted sexual intercourse during various intervals (>0 to < or = 1, >1 to < or = 4, and >4 to < or = 36, including >12 to < or = 36 h) after dosing with tadalafil or placebo over a 12-week period. Patients were stratified by age, baseline severity of ED, and previous history of sildenafil use. RESULTS: Of patients in different age groups and various ED severity, > or = 79% and > or = 53% chose to attempt sexual intercourse at least once during the 12-week treatment period at 4-36 and 12-36 h, respectively, after taking tadalafil. Regardless of previous experience with sildenafil, about a third of patients using tadalafil attempted intercourse a mean of at least once per week at 4-36 h after the dose over 12 weeks. Furthermore, 58% of patients attempted intercourse at least once during two intervals (>1 to < or = 4 h and >12 to < or = 36 h) after separate doses of tadalafil. CONCLUSION: Regardless of age, ED severity, or previous experience with sildenafil, most patients attempted sexual intercourse at least once at 12-36 h after one dose of tadalafil over a 12-week treatment period. Furthermore, by engaging in sexual intercourse at both earlier and later intervals after separate doses, most patients on treatment did not adhere to a fixed schedule of intimacy and thus took advantage of the 36-h duration.


Subject(s)
Carbolines/administration & dosage , Coitus/physiology , Erectile Dysfunction/drug therapy , Phosphodiesterase Inhibitors/administration & dosage , Adult , Aged , Aged, 80 and over , Double-Blind Method , Humans , Male , Middle Aged , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Tadalafil , Time Factors , Treatment Outcome
20.
Eur Urol ; 45(6): 806-10, 2004 Jun.
Article in English | MEDLINE | ID: mdl-15149757

ABSTRACT

OBJECTIVE: Urethrocutaneous fistula is a well-known complication of hypospadias surgery and is reported in 5-10% of repairs. Using a previously described juvenile pig model, we present a histological analysis of the healing of the ventral aspect of the urethral repair and describe the histological mechanism of fistula formation. MATERIALS AND METHODS: Twelve juvenile pigs underwent ventral, longitudinal urethral incision and closure over a 5-French feeding tube. The ventral aspect was closed in running fashion using two closure techniques and three suture types in each animal. Three animals were sacrificed on postoperative day 3, three on day 5, three on day 12, one on day 14, and two on day 21. Closure was one-layered incorporating urethral mucosa in the animals sacrificed on days 3, 5, and 21. An extra-mucosal suture technique was used in the group sacrificed on day 12. Sections of the penis were cut, paraffin embedded, and treated with Hematoxylin and Eosin staining. RESULTS: Fistulae were seen in 12 specimens and in association with each suture type. Fewer sections of the extra-mucosal technique showed fistulization. Fistulae lined with immature epithelium were seen by day 5. Mature fistulae were observed by day 12. Skin epithelium and urethral mucosa migrated along suture tracts. By days 12 and 21, in addition to mature fistulae, several sections showed well-healed ventral repairs with clearly extramucosal suture tracts. CONCLUSIONS: Fistula formation begins early in the healing process after ventral urethral repair. Incorporation of urethral mucosa in the ventral repair is a substrate for fistula formation with rapid migration of urethral mucosa and skin epithelium into suture tracts. The importance of a multi-layered repair and extra-mucosal suture technique are thus emphasized with respect to urethral repair. Whether the mucosal or dermal migration along suture tracts can be attenuated or prevented by changing the biochemical environment awaits further investigation.


Subject(s)
Cutaneous Fistula/pathology , Disease Models, Animal , Urethral Diseases/pathology , Urinary Fistula/pathology , Animals , Swine , Time Factors , Wound Healing
SELECTION OF CITATIONS
SEARCH DETAIL